Registration Dossier

Administrative data

Description of key information

Tartaric acid is skin and eye irritant.
Tartaric acid salts are not skin/eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In order to assess the irritating potential, tartaric acid has to be considered independently by its salts. Indeed, the acid has a low pH value whereas its salts have values greater than or equal to 3.

Based on clinical investigations (human data), tartaric acid is deemed to be irritant for both skin and eye. Indeed, skin and eye irritation signs were observed in several workers who handled the substance. Also respiratory irritation was observed; however, this effect was judged by the (medical) authors to be related to the overall dustiness of the investigated work environment.

With regard to tartaric acid salts, hydrogen potassium tartrate (pH = 3) was injected in the rabbit ocular chamber and did not cause any significant adverse effect. In a clinical study, a solution of sodium hydrogen tartrate (pH = 3.5) was tested in human eye in order to assess its irritating potential. Although the test solution caused moderate stinging and a sensation of dryness, no injury was observed. The same test solution neutralized at pH 6 did not cause discomfort.

In the same way, a solution of tartaric acid neutralized at pH 3 (adding sodium phosphate) was tested on human eye. As result, severe stinging was felt by the tested subject but no injury was observed.

Overall, the pH is deemed to be the factor driving the irritating potential of these substances. In particular, it was observed that the handling of tartaric acid (which has a pH close to 2) was associated with significant eye reactions. By contrast, test substances/solutions at pH equal to or higher than 3 caused only discomfort but no significant irritating effect (intended as damage or adverse reaction).

In conclusion, tartaric acid should be considered to be a sever eye irritant. On the other hand, considering that the pH values of the tartaric acid salts are equal to or greater than 3, these substances should not be considered as irritant for both skin and eye.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that tartaric acid should be classified as "Xi; R38" and as "skin irritant, category 2 (H315)", respectively.

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that tartaric acid should be classified as "Xi; R41" and as "eye damage, category 1 (H318)", respectively.

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the tartaric acid salts should not be classified for the skin/eye irritation because the data are judged as "conclusive but not sufficient for classification".

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that tartaric acid and its salts should not be classified for specific target organ toxicity - single exposure (H335) because data are judged as "inconclusive".